News and Blog

Previously on the blog, we focused on the regulatory and compliance risks surrounding compounded GLP‑1 products, particularly misbranding, quality concerns, and how quickly the enforcement landscape has evolved. Continuing this discussion, we broaden the lens to the developing litigation environment and additional regulatory scrutiny that can affect manufacturers, pharmacies, telehealth providers, and other stakeholders across the GLP‑1 ecosystem.

The new year has brought notable changes on the regulatory front for life science companies seeking to expand their portfolio of digital health products. In January 2026, the U.S. Food & Drug Administration (FDA) published updated guidance documents addressing two broad product categories: (1) low-risk digital health devices for general wellness use; and (2) clinical decision support (CDS) software.

As previously reported on our blog, the rise of compounded GLP-1 medications has sparked both excitement and concern across the healthcare and legal landscapes. As demand for weight-loss treatments increases, some pharmacies have begun offering compounded versions of popular drugs like semaglutide and tirzepatide.

Researchers and physicians have historically taken a compartmentalized approach to medicine: neurologists treat conditions of the brain, gastroenterologists address concerns of the digestive system, and psychiatrists administer care for mental health. Seldom have these specialties intersected in meaningful ways.

Most leaders tune out when they hear “tax credit.” That may be a mistake. R&D credits have quietly expanded and can unlock real strategic value for life sciences companies. I’ve spent enough time in boardrooms and leadership meetings to know that when someone says “tax credit,” most ears glaze over. It’s the kind of topic that lands squarely in the important but not urgent bucket. And yet, the conversations I’ve been having lately with experts in the life sciences are making me rethink that instinct.

Scientists have studied Alzheimer’s disease for over a century, since Alois Alzheimer’s initial description of brain abnormalities in a patient with presenile dementia. Today, amyloid‑beta plaques and tau tangles are recognized as hallmarks of the disease, though its causes are complex and multifactorial.

In 2023, Berkley Life Sciences published a blog post titled PFAS “Forever Chemicals” in Medical and Life Sciences Products – Who Should Be Worried?. At that time, most per- and polyfluoroalkyl substances (PFAS) litigation to date focused on lawsuits against PFAS manufacturers, alleging personal injury from PFAS exposure. Since then, PFAS litigation has evolved, and both the U.S. Food and Drug Administration (FDA) and European Chemicals Agency (ECHA) have issued updates, warranting a fresh look at this topic.

Montana's Right to Try laws - Senate Bill 422 (2023) and Senate Bill 535 (2025) allow any patient, not just those with terminal illness, to access experimental treatments that have passed Phase 1 safety trials. Clinics offering these treatments must be licensed and contribute to patient support funds. Patients must provide informed consent before treatment.

Traditional pediatric prosthetics present significant challenges for families and clinicians alike. These devices are often expensive, difficult to customize, and inaccessible to children in remote or low-income areas. Because children grow quickly, prosthetics require frequent replacements and adjustments, adding financial and logistical strain.

A transformative shift is underway in the life sciences sector, particularly regarding digital health products. Increasingly, life science companies are moving beyond developing medical technology solely for healthcare providers. Their focus now includes developing, marketing, and selling digital products directly to patients as consumers. Diagnostic tools such as self-administered glucose monitors, wearable electrocardiograms, and other self-administered tests, monitors, and therapies are increasingly common.